Quality adjusted life year gains associated with administration of recombinant tissue-type plasminogen activator for treatment of acute ischemic stroke: 1998-2011.

BACKGROUND: Intravenous recombinant tissue-type plasminogen activator (r-tPA) is an approved treatment for select patients with acute ischemic stroke (AIS). Data indicate r-tPA improves functional outcome three months after AIS compared with placebo. This study models the increase in quality adjusted life years (QALYs) associated with r-tPA compared with similar patients not treated with r-tPA. METHODS: Hospital discharge data for AIS and r-tPA were obtained from the Nationwide Inpatient Sample from 1998 to 2011. Discharge location (home, rehabilitation, long-term care, death) was mapped to modified Rankin Scale (mRS) scores based on National Institute of Neurological Disorders and Stroke (NINDS) Study Group Part 1 and 2 clinical studies. The mRS scores were mapped to relative risk of death and QALYs obtained from the literature. The model estimated expected survival and QALYs by age, gender and mRS for patients receiving r-tPA. Life expectancy and QALYs for patients not receiving r-tPA were estimated based on discharge location and mRS for placebo patients in the NINDS study. RESULTS: AIS discharges declined from over 635,000 in 1998 to over 593,000 in 2011. A total of 183,235 patients received r-tPA. Utilization of r-tPA increased from 1% of AIS patients in 1998 to over 4% in 2011. Estimated projections for QALYs gained from utilization of r-tPA to QALYS without r-tPA were just under 240,000 for the 13 years and with no discounting, and just over 165,000 assuming 3% annual discounting. In the most conservative scenario, assuming no difference in proportional discharge status (i.e. patients not treated with r-tPA are discharged in the same manner as r-tPA patients), the estimated life years gained are approximately 35,000 and QALYS gained are approximately 90,000. CONCLUSIONS: r-tPA for AIS has resulted in estimated gains in quality-adjusted life years due to reduction in disability and improvement in functioning since its introduction in 1998.

Progression of autosomal dominant kidney disease: measurement of the stage transitions of chronic kidney disease.

BACKGROUND: Autosomal dominant polycystic kidney disease (ADPKD) is a progressive genetic disorder characterized by the development of numerous kidney cysts that result in kidney failure. Little is known regarding the key patient characteristics and utilization of healthcare resources for ADPKD patients along the continuum of disease progression. This observational study was designed to describe the characteristics of ADPKD patients and compare them with those of patients with other chronic kidney diseases. METHODS: This retrospective cohort study involved patients with a claim for ADPKD or PKD unspecified from 1/1/2000-2/28/2013 and ≥6 months of previous continuous enrollment (baseline) within a large database of administrative claims in the USA. A random sample of chronic kidney disease (CKD) patients served as comparators. For a subset of ADPKD patients who had only a diagnosis code of unspecified PKD, abstraction of medical records was undertaken to estimate the proportion of patients who had medical chart-confirmed ADPKD. In patients with linked electronic laboratory data, the estimated glomerular filtration rate was calculated via serum creatinine values to determine CKD stage at baseline and during follow-up. Proportions of patients transitioning to another stage and the mean age at transition were calculated. RESULTS: ADPKD patients were, in general, younger and had fewer physician visits, but had more specific comorbidities at observation start compared with CKD patients. ADPKD patients had a longer time in the milder stages and longer duration before recorded transition to a more severe stage compared with CKD patients. Patients with ADPKD at risk of rapid progression had a shorter time-to-end-stage renal disease than patients with CKD and ADPKD patients not at risk, but stage duration was similar between ADPKD patients at risk and those not at risk. CONCLUSIONS: These results suggest that distribution of patients by age at transition to next stage may be useful for identification of ADPKD patients at risk of rapid progression. The results also suggest that medical claims with diagnosis codes for "unspecified PKD", in absence of a diagnosis code for autosomal recessive polycystic kidney disease, may be a good proxy for ADPKD.

Hospital-based inpatient resource utilization associated with autosomal dominant polycystic kidney disease in the US.

OBJECTIVE: Polycystic kidney disease (PKD) is a clinically and genetically heterogeneous class of genetic disorders characterized by development of renal cysts leading to renal failure and end stage renal disease (ESRD). Autosomal dominant polycystic kidney disease (ADPKD) accounts for the majority of PKD cases and is the predominant monogenic cause of ESRD. Limited information on patient characteristics and healthcare resource utilization is available in this population. This study assessed hospital-based inpatient utilization of patients with ADPKD in the US to help further understand the disease, which may lead to treatments that delay progression and reduce healthcare resource utilization. METHODS: A cross-sectional analysis was conducted using MedAssets Health System Data to investigate inpatient resource utilization for a total of 1876 patients hospitalized with ADPKD or chronic kidney disease (CKD). Patient characteristics and inpatient resource utilization were compared between hospitalized patients with ADPKD and CKD, including demographic and clinical characteristics, overall health, rates of complications and surgical interventions, and average length of hospital and intensive care unit stay. RESULTS: Compared with patients with CKD, patients with ADPKD were more likely to have commercial insurance as their primary payer (36.1 vs 17.8%) and were significantly younger (mean age 57.9 vs 69.5 years) and generally healthier (Charlson Comorbidity Score of 2.0 vs 3.3). Patients with ADPKD also had a substantially shorter average length of hospital stay (6.3 vs 10.3 days). However, patients with ADPKD experienced more kidney-related complications and a higher surgical procedure rate (mainly for transplant and complete nephrectomy). CONCLUSIONS: Although patients with ADPKD were generally healthier than patients with CKD, specific kidney function complications were more frequent. Patients with ADPKD had a higher rate of major kidney procedures, which may contribute to the high burden of ADPKD-related hospital-based inpatient resource utilization.

Patterns of care in community-based oncology practices for anemia associated with myelosuppressive chemotherapy.

Use of erythropoiesis-stimulating agents in the treatment of myelosuppresive chemotherapy-induced anemia has been shown to increase hemoglobin levels and reduce the need for transfusions in patients with cancer.

Watchful waiting and health related quality of life for patients with localized prostate cancer: data from CaPSURE.

PURPOSE: Watchful waiting is an alternative to active treatment for men with low risk prostate cancer but it is unclear how health related quality of life (HRQoL) may change over time for men who select this option. We report on HRQoL in men with localized prostate cancer who selected watchful waiting. MATERIALS AND METHODS: HRQoL outcomes were reviewed for 310 men diagnosed with prostate cancer from 1990 to 2001 within Cancer of the Prostate Strategic Urological Research Endeavor who chose watchful waiting. The UCLA Prostate Cancer Index and RAND 36-Item Health Survey were completed at enrollment and approximately every 6 months. A random slopes model was developed to assess time trends in HRQoL for up to 5 years after diagnosis, adjusting for age at diagnosis and specific comorbidities. RESULTS: Significant decreases with time were observed in 7 domains of the RAND 36-Item Health Survey and 4 of the UCLA Prostate Cancer Index scales. CONCLUSIONS: Men with prostate cancer who chose watchful waiting in the current study had better or similar HRQoL outcomes compared to men without prostate cancer at the start of the study. Many of these scores were significantly affected by increasing age and decreased with time. The physical domain scores as well as sexual function scores decreased more than expected from the aging process alone.

Insurance and quality of life in men with prostate cancer: data from the Cancer of the Prostate Strategic Urological Research Endeavor.

OBJECTIVE: To evaluate the effect of medical insurance coverage on health-related quality of life (HRQoL) outcomes in men newly diagnosed with prostate cancer, as insurance status has been shown to be related to clinical presentation, and types of treatments received for localized prostate cancer, but the relationship of insurance and QoL has not been explored sufficiently. PATIENTS AND METHODS: Data from the Cancer of the Prostate Strategic Urological Research Endeavor (CaPSURE), a national longitudinal database registry of men with prostate cancer, were used for this study. Men who were newly diagnosed at entry to CaPSURE and completed one questionnaire before treatment, and one or more afterwards, were included. Insurance groups specific to age distribution of the study population were assessed, i.e. Medicare, preferred provider organizations (PPOs), health maintenance organizations (HMOs), fee for service (FFS), and the Veterans Administration (VA) for the younger group, and Medicare only, Medicare plus supplement (+S), and HMO/PPO for the older group. Associations between patients' clinical and sociodemographic characteristics and insurance status were evaluated by chi-square and analysis of variance. Relationships between insurance status and HRQoL outcomes over time were evaluated by multivariate mixed model. RESULTS: Of 2258 men who met the study criteria, 1259 were younger and 999 were older than 65 years. More than half of the younger patients belonged to an HMO or PPO (42.2% and 32.5%, respectively), with the remainder distributed between Medicare, FFS and VA. In the older group most men belonged to Medicare only and the Medicare +S groups (22.4% and 58.8%, respectively). There was greater variation in clinical risk categories at presentation by insurance groups in the younger group. In the multivariate analysis, insurance status was significantly associated with changes in most HRQoL outcomes over time in the younger group, while in the older patients the effect of insurance diminished. Men in the VA and Medicare systems had lower scores at baseline and a steeper decline in Physical Function, Role Physical, Role Emotional, Social Function, Bodily Pain, Vitality, and General Health domains over time, controlling for type of initial treatment received, timing of HRQoL assessment, number of comorbidities, clinical risk at presentation, and income. CONCLUSION: Insurance was independently related to changes in a wide range of HRQoL outcomes in men aged <65 years treated for prostate cancer. With the latest advances in early diagnosis and treatment of prostate cancer, clinicians and researchers should be aware of the specific groups of patients who are more vulnerable to the adverse effects of treatment and subsequent decline in functioning. The present findings could provide important tools for understanding the process of recovery after treatment for prostate cancer, and identifying needs for specific services.

Assessment of prognosis with the total illness burden index for prostate cancer: aiding clinicians in treatment choice.

BACKGROUND: Among the most pressing challenges that face physicians who care for men with prostate cancer is evaluating the patient's potential for benefiting from treatment. Because prostate cancer often follows an indolent course, the presence and severity of comorbidities may influence the decision to treat the patient aggressively. The authors adapted the Total Illness Burden Index (TIBI) for use in decision-making among men with prostate cancer at the time of the visit. METHODS: An observational study was performed of 2894 participants in the Cancer of the Prostate Strategic Urologic Research Endeavor, a national disease registry of men with prostate cancer, to examine how well the adapted TIBI for prostate cancer (TIBI-CaP) predicted mortality over the subsequent 3.5 years and health-related quality of life over the subsequent 6 months. RESULTS: The men who had the highest global TIBI-CaP scores were 13 times more likely to die of causes other than prostate cancer over a 3.5-year period than the men who had the lowest scores (hazard ratio, 13.1, 95% confidence interval, 6.3-27.4) after controlling for age, education, income, and race/ethnicity. Patients who had the highest TIBI-CaP scores had 44% mortality compared with 4.9% mortality for patients who had the lowest scores. Demographic variables explained 16% of the variance in future physical function; TIBI-CaP scores explained an additional 19% of the variance. CONCLUSIONS: The TIBI-CaP, a patient-reported measure of comorbidity, identified patients at high risk for nonprostate cancer mortality. It predicted both mortality and future quality of life. The TIBI-CaP may aid physicians and patients in making appropriate treatment decisions.

Clinical and psychosocial characteristics of men with erectile dysfunction: baseline data from ExCEED.

INTRODUCTION: Erectile dysfunction (ED) is associated with psychological impairment, and further research is required to understand their relationship. AIM: We present descriptive baseline results from a longitudinal observational study of North American men seeking treatment for ED. METHODS: Patients completed clinical and health-related quality-of-life information at baseline and three follow-up points over 12 months; 162 patients had usable baseline data, including clinical history and current status, sociodemographic information, and standard paper-and-pencil scales of psychosocial characteristics. Scores on the International Index of Erectile Functioning erectile functioning subscale were collapsed into mild (N = 27), moderate (N = 41), or severe (N = 94) categories. Using chi-square, anova, and logistic regression, we identified baseline characteristics associated with ED severity. MAIN OUTCOME MEASURE: The main outcome measure was the degree of psychosocial impairment associated with mild, moderate, and severe ED. RESULTS: Severe ED was significantly associated with not having a regular sex partner; a history of prostate cancer; and worse scores on measures of positive affect, belonging/loneliness, sexual self-efficacy-strength, psychological adjustment, marital happiness, anxiety at last intercourse, and depression. In a multivariate logistic regression model, poorer sexual self-efficacy was most closely associated with severe ED. The model rescaled R(2) was 0.63 (area-under-the-curve, 0.91). CONCLUSIONS: Severe ED is related to impairment across a broad range of psychosocial domains, and clinicians should consider offering patients assistance in dealing with its psychosocial impact.

Longitudinal differences in psychological outcomes for men with erectile dysfunction: results from ExCEED.

INTRODUCTION: The direction of the relationship between psychological adjustment and erectile dysfunction (ED) is unclear and may differ for different men, and few studies have examined psychological outcomes for men receiving ED treatment. AIM: This study assessed the impact of ED therapy at baseline and 12-month follow-up, using standard psychological measures. METHODS: Using an observational ED registry, we collected clinical and psychosocial data at baseline and 3, 6, and 12 months. Participants had (i) a patient-reported outcomes questionnaire at baseline and at least one follow-up; and (ii) data about ED treatments received during the study. Treated men were classified as responders based on improvements in International Index of Erectile Function scores from baseline to 12 months. MAIN OUTCOME MEASURES: The main outcome measures were changes in psychological outcomes in relation to treatment status and baseline ED severity. RESULTS: Of 153 patients, 40 responded to treatment, 49 did not respond to treatment, and 64 did not receive treatment. Treatment responders reported significant improvements in 12-month sexual self-efficacy but only small improvements or no change across five other psychological domains, whereas nonresponders reported small decrements. There was a trend for differences in sexual self-efficacy to vary by baseline ED severity, as well as by treatment response. CONCLUSIONS: Diagnosing and successfully treating ED significantly affects patient psychological adjustment, so providers should actively diagnose and treat ED.

Revalidation of the original Cedars-Sinai health-related quality of life in rheumatoid arthritis questionnaire.

OBJECTIVE: To assess the psychometric characteristics of the original 33-item Cedars-Sinai Health-Related Quality of Life in Rheumatoid Arthritis Questionnaire (O-CSHQ-RA) and 11-item CSHQ-RA Short Form (SF) using a representative population of patients with rheumatoid arthritis (RA) from 55 sites across the United States. METHODS: Data were from a 24-week multicenter, open-label, single-arm study of 312 RA patients receiving anakinra. Cronbach's alpha coefficient was used to indicate the internal consistency. Test-retest reliability was assessed by establishing the intraclass correlation coefficient (ICC) for screening and baseline visit responses. Convergent validity was tested with the Pearson correlation coefficient. Analysis of variance was performed to determine discriminant validity. A Wilcoxon signed-rank test and analysis of covariance were used to assess the responsiveness. A discriminant function was generated to determine the clinically meaningful change. RESULTS: Test-retest reliability was demonstrated for both versions of the CSHQ-RA, with ICC ranging from 0.82 to 0.94. Cronbach's alpha coefficients were > or = 0.9, indicating good internal consistency. Pearson correlations between health-related quality of life instruments and CSHQ-RA measures ranged from -0.33 to -0.73 and 0.39 to 0.76, demonstrating good convergent validity. Scores on both versions of the CSHQ-RA differed significantly (p < 0.0001) for patients with different levels of physical disability as measured by the Stanford Health Assessment Questionnaire. Both instruments were responsive to differences in patient health as measured by the general health question (p < 0.0001). Clinically meaningful changes were calculated for all 5 domains of the O-CSHQ-RA (6.9-14.0) and the overall O-CSHQ-RA SF (12.7). CONCLUSION: These results support the validity and reliability of both the original CSHQ-RA and the 11-item CSHQ-RA SF when tested in a representative patient population.

Aerobic exercise and its impact on musculoskeletal pain in older adults: a 14 year prospective, longitudinal study.

We studied the long term impact of running and other aerobic exercise on musculoskeletal pain in a cohort of healthy aging male and female seniors who had been followed for 14 years. We conducted a prospective, longitudinal study in 866 Runners' Association members (n = 492) and community controls (n = 374). Subjects were also categorized as Ever-Runners (n = 565) and Never-Runners (n = 301) to include runners who had stopped running. Pain was the primary outcome measure and was assessed in annual surveys on a double-anchored visual analogue scale (0 to 100; 0 = no pain). Baseline differences between Runners' Association members and community controls and between Ever-Runners versus Never-Runners were compared using chi-square and t-tests. Statistical adjustments for age, body mass index (BMI), gender, health behaviors, history of arthritis and comorbid conditions were performed using generalized estimating equations. Runner's Association members were younger (62 versus 65 years, p < 0.05), had a lower BMI (22.9 versus 24.2, p < 0.05), and less arthritis (35% versus 41%, p > 0.05) than community controls. Runners' Association members averaged far more exercise minutes per week (314 versus 123, p < 0.05) and miles run per week (26 versus 2, p < 0.05) and tended to report more fractures (53% versus 47%, p > 0.05) than controls. Ever-Runners were younger (62 versus 66 years, p < 0.05), had lower BMI (23.0 versus 24.3, p < 0.05), and less arthritis (35% versus 43%, p < 0.05) than Never-Runners. Ever-Runners averaged more exercise minutes per week (291 versus 120, p < 0.05) and miles run per week (23 versus 1, p < 0.05) and reported a few more fractures (52% versus 48%, p > 0.05) than Never-Runners. Exercise was associated with significantly lower pain scores over time in the Runners' Association group after adjusting for gender, baseline BMI, and study attrition (p < 0.01). Similar differences were observed for Ever-Runners versus Never-Runners. Consistent exercise patterns over the long term in physically active seniors are associated with about 25% less musculoskeletal pain than reported by more sedentary controls, either by calendar year or by cumulative area-under-the-curve pain over average ages of 62 to 76 years.

Demographics, insurance coverage, and utilization of medical services in newly diagnosed prostate cancer: data from caPSURE.

This study was conducted to identify factors that might influence access to medical services by patients with prostate cancer. The sample comprised 1882 patients who underwent radical prostatectomy and received at least six months of posttreatment follow-up. The investigators found that the type of insurance coverage significantly influenced the number of visits to general practitioners, mental health professionals, and oncologists. However, visits to urologists, nurse practitioners, or alternative-therapy providers were not influenced by type of insurance coverage. Moreover, race, risk profile, and education were significantly correlated with utilization of health services by these patients. The influence of demographic features and insurance coverage on health care utilization by patients with prostate cancer should be further explored.

Ability of 2 pretreatment risk assessment methods to predict prostate cancer recurrence after radical prostatectomy: data from CaPSURE.

PURPOSE: Two methods widely used to predict the risk of treatment failure after radical prostatectomy for localized prostate cancer are the 3 level D'Amico risk classification and the Kattan nomogram. Although they have been previously validated, to our knowledge they have not been compared in a community based cohort. We tested the 2 instruments in the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) database, a national registry of patients with prostate cancer, to assess their accuracy in a community based cohort. MATERIALS AND METHODS: Men were invited to join CaPSURE from 33 American urology practices, of which 30 were community based. A total of 1,701 men with localized prostate cancer (T1-3a) were treated with radical prostatectomy between 1989 and 2000. Patients who received neoadjuvant or adjuvant therapy were excluded. Recurrence was defined as 2 or more consecutive prostate specific antigen measurements of 0.2 ng/ml or greater, or a second treatment greater than 6 months after surgery. Freedom from progression (FFP) was based on life table estimates and Kaplan-Meier curves. Risk groups were compared using a Cox proportional hazards model and ANOVA. RESULTS: Based on the D'Amico classification 671 cases (39%) were classified as low risk, 446 (26%) were intermediate risk and 584 (34%) were high risk. Five-year FFP was 78%, 63% and 60% in the low, intermediate and high risk groups (HR 1.00, 1.87 and 2.32 respectively, p <0.0001). Mean 5-year FFP predicted by the Kattan nomogram in the same risk groups was 91%, 74% and 69%, respectively. Outcomes in the low risk group were tightly grouped about the mean but there was considerable dispersion of outcomes in the intermediate (30% to 98% FFP) and high (17% to 98%) risk groups. CONCLUSIONS: Stratifying patients in CaPSURE into low, intermediate and high risk categories for disease as described by D'Amico or applying the Kattan nomogram resulted in statistically significant differences in predicted 5-year FFP. However, there was considerable overlap of outcomes between the intermediate and high risk groups. This analysis suggests that simply estimating disease recurrence by stratifying patients into low, intermediate and high risk groups may not provide sufficient information for predicting outcomes among individuals.

Self-report was a viable method for obtaining health care utilization data in community-dwelling seniors.

OBJECTIVE: Patient self-report and audits of medical records are the most common approaches for obtaining information on utilization of medical services. Because of the time and cost savings associated with self-report, it is important to demonstrate the reliability of this approach, particularly in older persons who use more medical resources but may have poorer recall. STUDY DESIGN AND SETTING: We contacted the medical providers of a random sample of seniors (n = 150) who participated in an ongoing study of health care use. Providers' reports on the participant's medical utilization in the prior year were compared with patients' self-report over the same time period using weighted kappa statistics. RESULTS: Perfect or almost perfect agreement (weighted kappa = 0.80-1.00) was obtained for physician, hospital, and emergency department visits and high-cost therapies (chemotherapy, radiation therapy). Agreement was substantial (weighted kappa = 0.60-0.80) for x-ray procedures and prescription medications and moderate (weighted kappa = 0.40-0.60) for outpatient procedures and diagnostic tests. CONCLUSION: Participant self-report is a viable, reasonably accurate method to obtain information on most types of medical utilization in an older study cohort.

Watchful waiting and health related quality of life for patients with localized prostate cancer: data from CaPSURE.

PURPOSE: Watchful waiting is an alternative to active treatment for men with low risk prostate cancer but it is unclear how health related quality of life (HRQoL) may change over time for men who select this option. We report on HRQoL in men with localized prostate cancer who selected watchful waiting. MATERIALS AND METHODS: HRQoL outcomes were reviewed for 310 men diagnosed with prostate cancer from 1990 to 2001 within Cancer of the Prostate Strategic Urological Research Endeavor who chose watchful waiting. The UCLA Prostate Cancer Index and RAND 36-Item Health Survey were completed at enrollment and approximately every 6 months. A random slopes model was developed to assess time trends in HRQoL for up to 5 years after diagnosis, adjusting for age at diagnosis and specific comorbidities. RESULTS: Significant decreases with time were observed in 7 domains of the RAND 36-Item Health Survey and 4 of the UCLA Prostate Cancer Index scales. CONCLUSIONS: Men with prostate cancer who chose watchful waiting in the current study had better or similar HRQoL outcomes compared to men without prostate cancer at the start of the study. Many of these scores were significantly affected by increasing age and decreased with time. The physical domain scores as well as sexual function scores decreased more than expected from the aging process alone.

Longitudinal assessment of changes in sexual function and bother in patients treated with external beam radiotherapy or brachytherapy, with and without neoadjuvant androgen ablation: data from CaPSURE.

PURPOSE: To evaluate the effects of external beam radiotherapy (EBRT), with or without brachytherapy (BT) boost or brachytherapy monotherapy with and without short-term androgen ablation (<==6 months; STAD) on sexual function (SF) and sexual bother (SB) in men treated for localized prostate cancer. METHODS AND MATERIALS: A total of 992 men with newly diagnosed prostate cancer enrolled in the Cancer of the Prostate Strategic Urological Research Endeavor database were studied to assess treatment-related changes in SF and SB. Six treatment subgroups (EBRT - STAD, EBRT + STAD, BT - STAD, BT + STAD, EBRT + BT - STAD, EBRT + BT + STAD) were compared. RESULTS: The greatest reported changes in SF occurred during the first 2 posttreatment years. Patients receiving BT reported greater SF and the least change in SF overall; those receiving EBRT + BT reported the greatest decline in SF. SF scores associated with STAD were initially lower than in patients without STAD; however by 1 year no statistically significant difference in SF or SB was noted. CONCLUSION: Each treatment for prostate cancer can negatively affect SF and SB. Initial differences among treatment subgroups exist, but diminish with time. SF changes associated with EBRT +/- BT were statistically significant and those for BT were not. STAD appeared to confer only temporary and recoverable impairment of erectile function.

Bowel function and bother after treatment for early stage prostate cancer: a longitudinal quality of life analysis from CaPSURE.

PURPOSE: We measured bowel function and bowel bother longitudinally the first 2 years after treatment for early stage prostate cancer. MATERIALS AND METHODS: We studied bowel function and bother in 1,584 men recently diagnosed with early stage prostate cancer and followed for 2 years after radical prostatectomy, external beam radiation or brachytherapy. Principal outcomes were assessed with the UCLA Prostate Cancer Index, a validated instrument that includes these 2 domains. Multivariate analyses were conducted to ascertain significant predictors of bowel function and bother. Subjects were drawn from Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE, TAP Pharmaceutical Products, Inc., Lake Forest, Illinois), a national, longitudinal registry of men with prostate cancer. RESULTS: Men treated with external beam radiation or brachytherapy suffered worse bowel function and were more bothered by it than men treated surgically. After an initial period of posttreatment impairment, all 3 groups demonstrated improvement with time in both domains, although bowel bother persisted longer in men treated with external beam radiation. Surgery patients reached a steady state by 3 months, while those treated with external beam radiation or brachytherapy continued to improve for more than a year after treatment. Older men were more bothered by bowel dysfunction than younger men. Ethnicity, comorbidity and education did not affect either bowel function or bother. CONCLUSIONS: Patients undergoing surgery, external beam radiation or brachytherapy have different longitudinal profiles of bowel function and bother during the first 2 years after treatment. Bowel function and bother are worse after external beam radiation but they are also impaired after brachytherapy. Men choosing surgery experience transient impairment in the bowel domains. This information may be useful to patients making treatment decisions for early stage prostate cancer.

Development and validation of Cedars-Sinai Health-Related Quality of Life in Rheumatoid Arthritis (CSHQ-RA) short form instrument.

OBJECTIVE: To develop an abridged version of the 33-item Cedars-Sinai Health-Related Quality of Life in Rheumatoid Arthritis instrument (CSHQ-RA) and test the validity and reliability of the abridged instrument. METHODS: Items from the original 33-item, 5-domain CSHQ-RA were assessed using psychometric and regression analyses of survey responses from 274 patients with rheumatoid arthritis. Items were retained in the final instrument based on statistical analysis and evaluation by an expert panel. Test-retest reliability, internal consistency, convergent and discriminant validity, and ceiling and floor effects were examined for the shortened CSHQ-RA. RESULTS: Statistical analysis and expert assessment yielded an 11-item instrument including questions in 4 domains. Test-retest reliability and internal consistency were high and the instrument showed good convergent and discriminant validity. CONCLUSION: The abridged CSHQ-RA short form is a valid and reliable instrument that can be used to examine the impact of RA on patients' health-related quality of life. Prospective validation in clinical trial settings is warranted.

The changing face of low-risk prostate cancer: trends in clinical presentation and primary management.

PURPOSE: Early intervention for prostate cancer is associated with excellent long-term survival, but many affected men, especially those with low-risk disease characteristics, might not experience adverse impact to survival or quality of life were treatment deferred. We sought to characterize temporal trends in clinical presentation and primary disease management among patients with low-risk prostate cancer. METHODS: Data were abstracted from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), a disease registry of 8,685 men with various stages of prostate cancer. Included were 2,078 men who were diagnosed between 1989 and 2001 and had a serum prostate specific antigen

Patient-reported outcomes and their role in the assessment of rheumatoid arthritis.

Patients with rheumatoid arthritis (RA) face considerable physical, social and emotional disabilities. In this chronic disease, for which a cure is not yet available, improving patients' health-related quality of life (HRQoL) is of the utmost concern, particularly as the use of long-term and potentially toxic therapy increases. Early HRQoL outcome measures in RA focused on physical functioning, but the social and emotional aspects of the disease are now increasingly important. Thus, several generic and RA-specific HRQoL instruments have been developed, but no one tool covers all areas of HRQoL that affect the patient with RA. For this reason, a combination of generic and disease-specific tools is currently recommended for RA clinical trials.